Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial

Completed · Not applicable

Conditions studied: Chronic, Intractable Pain of the Trunk and/or Lower Limbs

In brief

Prospective, multi-center, randomized, single blind study

Key facts

Study ID

NCT03277378

Run by

Abbott Medical Devices

People needed

270

Starts

2017-09-22

Expected to finish

2018-10-12

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient indicated for Spinal Cord Stimulation therapy in accordance with the approved labeling.
• Patient's pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage.
• Patient has a baseline score on the Numerical Rating Scale ≥6 over the past 24 hours for 'average overall pain'specific to the area(s) of chronic pain that will be treated with spinal cord stimulation.
• Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use.
• Patient is >18 years of age at the time of enrollment.
• Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits.
• Patient has signed and received a copy of the Ethical Committee/Independent Review Board approved informed consent.

You may not qualify if…

• Patient currently has a spinal cord stimulation system implanted.
• Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant).
• Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
• Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure)
• Patient is scheduled to be implanted with (a) surgical paddle trial lead(s).

Where it is running

• Jason Edward Pope, MD — Santa Rosa, California, United States
• Comprehensive Spine Institute — Clearwater, Florida, United States
• Florida Pain Institute — Merritt Island, Florida, United States
• National Pain Institute Winter Park — Winter Park, Florida, United States
• Rush University — Chicago, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Advanced Pain Care — Las Vegas, Nevada, United States
• Nevada Advanced Pain Specialists — Reno, Nevada, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Spinal Diagnostics — Tualatin, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Precision Spine Care — Tyler, Texas, United States
• St. Mary's Hospital — Huntington, West Virginia, United States
• Frankston Pain Management — Frankston, Australia
• North Shore Private Hospital — Saint Leonards, Australia
• Hospital Elisabethinen GmbH — Graz, Austria
• Wilhelminenspital Wien — Vienna, Austria
• Sana Kliniken Duisburg Gm.bH — Duisburg, Germany
• Medizinische Einrichtungen der Universität Düsseldorf — Düsseldorf, Germany
• Hospital Gera -Zentrum für interdisziplinäre Schmerztherapie — Gera, Germany
• Klinikum Nürnberg Sud — Nuremberg, Germany
• Fondazione Salvatore Maugeri — Pavia, Italy
• Alrijne Ziekenhuis — Leiderdorp, Netherlands
• Stichting Rijnstate Ziekenhuis - Velp — Velp, Netherlands
• University Hospital — Uppsala, Sweden

Full record on ClinicalTrials.gov

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